Process Compliance Specialist-Manufacturing

Regeneron Pharmaceuticals, Inc.; Limerick; On-site; EUR 37,000 - 88,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Ireland is seeking a Process Compliance Specialist to join our Manufacturing team in Limerick. The role focuses on troubleshooting manufacturing processes, developing personnel, and driving CAPA, with emphasis on cGMP compliance and documentation.

You will collaborate across functions to monitor trends, lead technology transfer, and ensure timely completion of validation activities, while maintaining high safety and quality standards.

Qualifications

• BS/BA/BEng in Life Sciences or related field and 2 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry or equivalent combination of education and experience
• Sr Specialist: BS/BA/BEng in Life Sciences or related field and 5 years experience

Responsibilities

• Providing technical expertise to troubleshoot and resolve manufacturing process issues both on and off the production floor
• Coaching and developing manufacturing personnel to strengthen technical knowledge, process understanding, and operational capability
• Supporting process improvements, CAPA implementation, and work system enhancements to drive performance and compliance
• Leading technology transfer, process startup activities, and cross-functional collaboration with Process Science and Technology Transfer teams
• Monitoring, analyzing, and presenting process trends, technical metrics, and operational data to support informed decision-making
• Conducting investigations into process variances and ensuring adherence to cGMP, regulatory requirements, site procedures, and safety standards
• Overseeing validation activities, equipment ownership responsibilities, and the scheduling of non-routine manufacturing operations
• Authoring, reviewing, and approving controlled documentation while representing Manufacturing during audits and driving continuous improvement initiatives

Skills

Troubleshooting

Process troubleshooting

Data analysis

Cross-functional collaboration

Education

BS/BA/BEng in Life Sciences or related field

2 years relevant cGMP manufacturing/engineering/scientific experience

5 years experience (Sr Specialist)

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently seeking a Process Compliance Specialist o join our Manufacturing team. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Limerick
• Days (Monday to Friday)

What you'll do:

• Providing technical expertise to troubleshoot and resolve manufacturing process issues both on and off the production floor
• Coaching and developing manufacturing personnel t strengthen technical knowledge, process understanding, and operational capability
• Supporting process improvements, CAPA implementation, and work system enhancements to drive performance and compliance
• Leading technology transfer, process startup activities, and cross-functional collaboration with Process Science and Technology Transfer teams
• Monitoring, analyzing, and presenting process trends, technical metrics, and operational data to support informed decision-making
• Conducting investigations into process variances and ensuring adherence to cGMP, regulatory requirements, site procedures, and safety standards
• Overseeing validation activities, equipment ownership responsibilities, and the scheduling of non-routine manufacturing operations
• Authoring, reviewing, and approving controlled documentation while representing Manufacturing during audits and driving continuous improvement initiatives

The environment and physical rhythms of this role:

• Collaborating effectively across functions to achieve shared business objectives
• Demonstrate technical problem-solving capability
• Ability to prioritise and balance multiple tasks simultaneously

Let's find out if we're a fit:

• BS/BA/BEng in Life Sciences or related field and 2 years of relevant cGMP manufacturing/engineering/scientific experience in a relevant industry or equivalent combination of education and experience
• Sr Specialist: BS/BA/BEng in Life Sciences or related field and 5 years experience

Thrive today. Grow tomorrow.

Does this sound like you?

We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

€37,000.00 - €88,400.00